BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER SUPPORT CATHETER

    MDR report key: 1850952 · Received September 28, 2010

    Report

    Report Number
    2183870-2010-00158
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS DID NOT INDICATE ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PT HAD BILATERAL ILIAC STENTS FROM A PRIOR PROCEDURE AND THE PHYSICIAN WAS ABLE TO GET A WIRE UP AND OVER THE ARCH FROM THE LEFT ACCESS. THIS CATHETER COULD NOT CROSS. THE PHYSICIAN THEN UTILIZED A TRAILBLAZER WHICH SUCCESSFULLY PASSED THROUGH BILATERAL ILIAC STENTS TO ACCESS THE RIGHT SIDE. DURING AN ATTEMPT TO EXCHANGE FOR A DIFFERENT .035 WIRE, THE WIRE WOULD NOT PASS THROUGH THE CATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE TRAILBLAZER CATHETER BUT IT WAS EXTREMELY TIGHT. THE PHYSICIAN WAS EVENTUALLY ABLE TO RETRIEVE THE CATHETER BUT NOTICED THAT MARKERS OF THE TRAILBLAZER WERE STILL PRESENT IN THE RIGHT ILIAC, INDICATING THAT THE DEVICE HAD SEPARATED AND THE DISTAL END WAS STUCK IN THE RIGHT ILIAC. THE PHYSICIAN SPENT ABOUT 90 MINUTES OBTAINING ACCESS IN THE RIGHT FEMORAL ARTERY, AFTER WHICH, A SNARE WAS USED TO GRAB THE TRAILBLAZER TIP. THE CATHETER PIECE WAS SUCCESSFULLY REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED AND NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAILBLAZER SUPPORT CATHETER DQY EV3 INC. SC-035-065 8519105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROTEGE EVERFLEX| GLIDE WIRES| 2 NANOCROSS PTA BALLOONS